Drug · FAERS side-effect profile with label screen

Cyclosporine Ophthalmic side effects: what 4,969 FDA adverse event reports show

Cyclosporine Ophthalmic Solution · 38 reaction terms · 6,757 drug–reaction co-reports · data 2026-09-14

Drug class

Calcineurin Inhibitor Immunosuppressant

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Cyclosporine Ophthalmic Solution (Vevye)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

4,969 reports · 1% serious · 4 with death outcome · 89% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VEVYE indicated for the treatment of the signs and symptoms of dry eye disease. VEVYE (cyclosporine ophthalmic solution) 0.1% is a calcineurin inhibitor immunosuppressant indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )

FDA label, Indications and Usage

What it is

VEVYE (cyclosporine ophthalmic solution) 0.1% contains the immunomodulatory agent cyclosporine. Cyclosporine's chemical name is Cyclo[[€-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoy.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 22 strongest signals

Reporting / coding artifact 4No label text to screen 18

What the badges mean

Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 16 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Eye irritation	2,027	159.2 153.8–164.8ROR 268.2 · χ² 307,635 / p <1e-300	153.2 EB05 147.7 · IC025 +7.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 51.4 · 99% consumer	no trial data cached
Ocular discomfort	202	80.0 69.8–91.6ROR 83.3 · χ² 15,384 / p <1e-300	77.9 EB05 69.3 · IC025 +5.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 97% consumer	no trial data cached
Eye pain	742	57.5 53.7–61.4ROR 67.4 · χ² 40,650 / p <1e-300	56.6 EB05 53.3 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 64.2 · 97% consumer	no trial data cached
Eye pruritus	338	43.7 39.4–48.5ROR 46.8 · χ² 13,934 / p <1e-300	43.2 EB05 39.4 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.2 · 99% consumer	no trial data cached
Ocular hyperaemia	448	40.8 37.4–44.6ROR 44.8 · χ² 17,243 / p <1e-300	40.4 EB05 37.3 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.2 · 99% consumer	no trial data cached
Lacrimation increased	219	31.1 27.4–35.5ROR 32.5 · χ² 6,322 / p <1e-300	30.8 EB05 27.6 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	96% consumer	no trial data cached
Eye discharge	64	26.6 20.8–33.9ROR 26.9 · χ² 1,542 / p <1e-300	26.2 EB05 21.3 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 100% consumer	no trial data cached
Dry eye	248	21.7 19.2–24.5ROR 22.8 · χ² 4,863 / p <1e-300	21.6 EB05 19.4 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.8 · 94% consumer	no trial data cached
Eye swelling	127	14.5 12.2–17.3ROR 14.9 · χ² 1,585 / p <1e-300	14.4 EB05 12.4 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.9 · 96% consumer	no trial data cached
Eye inflammation	28	12.6 8.7–18.2ROR 12.6 · χ² 286 / p 2e-64	12.0 EB05 8.4 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	96% consumer	no trial data cached
Vision blurred (blurred vision)	372	11.5 10.4–12.7ROR 12.4 · χ² 3,576 / p <1e-300	11.5 EB05 10.5 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.4 · 99% consumer	no trial data cached
Photophobia (light sensitivity)	43	9.7 7.2–13.1ROR 9.8 · χ² 328 / p 1e-73	9.2 EB05 7.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.3 · 98% consumer	no trial data cached
Product odour abnormal	23	9.4 6.2–14.1ROR 9.4 · χ² 163 / p 1e-37	8.4 EB05 5.7 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	91% consumer	no trial data cached
Vitreous floaters	15	6.5 3.9–10.8ROR 6.5 · χ² 64 / p 5e-16	5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Eye infection	12	4.5 2.6–8.0ROR 4.5 · χ² 29 / p 3e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Drug ineffective (drug did not work)	1,296	4.2 4.0–4.4ROR 5.3 · χ² 3,308 / p <1e-300	4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.7 · 99% consumer	no trial data cached
Eye disorder	27	3.5 2.4–5.1ROR 3.5 · χ² 45 / p 9e-12	3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.9 · 92% consumer	no trial data cached
Drug hypersensitivity	156	3.4 2.9–4.0ROR 3.5 · χ² 263 / p 2e-59	3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.2 · 100% consumer	no trial data cached
Product use complaint	10	2.7 1.5–5.1ROR 2.7 · χ² 9 / p 0.001	2.5 EB05 1.5 · IC025 +0.3	Reporting / coding artifact	serious n=1	no trial data cached
Product quality issue	84	2.6 2.1–3.3ROR 2.7 · χ² 84 / p 3e-20	2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	95% consumer	no trial data cached
Hypersensitivity (allergic reaction)	108	2.5 2.0–3.0ROR 2.5 · χ² 93 / p 3e-22	2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 2.0 · 97% consumer	no trial data cached
Diplopia (double vision)	13	2.1 1.2–3.6ROR 2.1 · χ² 7 / p 0.005	2.0 EB05 1.3 · IC025 +0.1	No label text to screen label has no adverse-reaction text	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Eye irritation	2,027	159.2 153.8–164.8ROR 268.2 · χ² 307,635 / p <1e-300	153.2 EB05 147.7 · IC025 +7.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 51.4 · 99% consumer	no trial data cached
Drug ineffective (drug did not work)	1,296	4.2 4.0–4.4ROR 5.3 · χ² 3,308 / p <1e-300	4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.7 · 99% consumer	no trial data cached
Eye pain	742	57.5 53.7–61.4ROR 67.4 · χ² 40,650 / p <1e-300	56.6 EB05 53.3 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 64.2 · 97% consumer	no trial data cached
Ocular hyperaemia	448	40.8 37.4–44.6ROR 44.8 · χ² 17,243 / p <1e-300	40.4 EB05 37.3 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.2 · 99% consumer	no trial data cached
Vision blurred (blurred vision)	372	11.5 10.4–12.7ROR 12.4 · χ² 3,576 / p <1e-300	11.5 EB05 10.5 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.4 · 99% consumer	no trial data cached
Eye pruritus	338	43.7 39.4–48.5ROR 46.8 · χ² 13,934 / p <1e-300	43.2 EB05 39.4 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.2 · 99% consumer	no trial data cached
Dry eye	248	21.7 19.2–24.5ROR 22.8 · χ² 4,863 / p <1e-300	21.6 EB05 19.4 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.8 · 94% consumer	no trial data cached
Lacrimation increased	219	31.1 27.4–35.5ROR 32.5 · χ² 6,322 / p <1e-300	30.8 EB05 27.6 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	96% consumer	no trial data cached
Ocular discomfort	202	80.0 69.8–91.6ROR 83.3 · χ² 15,384 / p <1e-300	77.9 EB05 69.3 · IC025 +5.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 97% consumer	no trial data cached
Drug hypersensitivity	156	3.4 2.9–4.0ROR 3.5 · χ² 263 / p 2e-59	3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.2 · 100% consumer	no trial data cached
Eye swelling	127	14.5 12.2–17.3ROR 14.9 · χ² 1,585 / p <1e-300	14.4 EB05 12.4 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.9 · 96% consumer	no trial data cached
Hypersensitivity (allergic reaction)	108	2.5 2.0–3.0ROR 2.5 · χ² 93 / p 3e-22	2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 2.0 · 97% consumer	no trial data cached
Product quality issue	84	2.6 2.1–3.3ROR 2.7 · χ² 84 / p 3e-20	2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	95% consumer	no trial data cached
Eye discharge	64	26.6 20.8–33.9ROR 26.9 · χ² 1,542 / p <1e-300	26.2 EB05 21.3 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2 · 100% consumer	no trial data cached
Photophobia (light sensitivity)	43	9.7 7.2–13.1ROR 9.8 · χ² 328 / p 1e-73	9.2 EB05 7.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.3 · 98% consumer	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Cyclosporine ↔ Nephrotoxicity.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Cyclosporine Ophthalmic?

In FDA FAERS, the most frequently co-reported reaction terms for Cyclosporine Ophthalmic are eye irritation, eye pain, ocular hyperaemia, vision blurred, eye pruritus, dry eye. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Cyclosporine Ophthalmic have an FDA boxed warning?

No. The FDA label retrieved for Cyclosporine Ophthalmic has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Cyclosporine Ophthalmic causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 0a60fccf-7e1b-44fe-e063-6394a90aadd5, effective 20260226; matched on openfda.generic_name.exact:"CYCLOSPORINE OPHTHALMIC SOLUTION")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 38 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.